Comparing Raltegravir Genital Tract Distribution in HIV-infected Men and Women

Official Title ICMJE

Comparing Raltegravir Genital Tract Distribution in HIV-infected Men and Women

Brief Summary

The purpose of this research study is to determine how much raltegravir gets into the male and female genital tract.

Detailed Description

Although we have many medications to fight the HIV virus, very little is known about how much of these medications get into the genital tract. Raltegravir is a new HIV medication that blocks HIV growth and lowers the amount of virus in the blood in a way that is different than all other currently available HIV medications. Raltegravir was recently approved by the Food and Drug Administration (FDA) for use in HIV infected patients, but there is very little information concerning how much raltegravir will reach the genital tract of men or women. The purpose of this research study is to determine how much raltegravir gets into the male and female genital tract.

Study Type ICMJE

Interventional

Study Phase

Not Provided

Study Design ICMJE

Endpoint Classification: Pharmacokinetics StudyIntervention Model: Single Group AssignmentMasking: Open Label

Condition ICMJE

HIV Infections

Intervention ICMJE

Drug: Raltegravir

400 mg tablets twice daily during duration of trial

Study Arm (s)

Experimental: Raltegravir

Raltegravir 400 mg tablets twice daily

Intervention: Drug: Raltegravir

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Completed

Enrollment ICMJE

28

Completion Date

June 2011

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria:

Documentation of blood seropositive for HIV based on self report and confirmed by ELISA and Western blot or detectable HIV RNA

Evidence of organ dysfunction or any clinically significant deviation from normal in the medical history, physical examination, vital signs, and or clinical laboratory determinations that in the opinion of the investigator would preclude the subject from safely participating in the study

Any other sound medical, psychiatric and or social reason for exclusion as determined by the investigator

History of allergy to study medication or related compounds

Gender

Both

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

No

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects